CN104847139A - Clean cell production workshop - Google Patents
Clean cell production workshop Download PDFInfo
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- CN104847139A CN104847139A CN201510172240.4A CN201510172240A CN104847139A CN 104847139 A CN104847139 A CN 104847139A CN 201510172240 A CN201510172240 A CN 201510172240A CN 104847139 A CN104847139 A CN 104847139A
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Abstract
The invention provides a clean cell production workshop. The clean cell production workshop is characterized by comprising a cleaning and disinfection room, a clean production workshop and a positive room. The cleaning and disinfection room is used for conducting cleaning and disinfection on the material flow. The clean production workshop comprises a plurality of operating units, a changing room, an air lock room connected with the changing room, and a consumable handover room. The positive room is independent of the clean production workshop, and is provided with an independent people flow one-way channel and an independent material flow one-way channel. The operating units are arranged to form two rows, a clean passage is formed between the two rows of operating units, and dirt passages are formed on the outer sides of the two rows of operating units. One end of the consumable handover room is connected with the cleaning and disinfection room through a delivery window, and the other end of the consumable handover room is connected with the operating unit at the foremost end. The people flow passes through the changing room and the air lock room to enter the clean passage, and the material flow passes through the cleaning and disinfection room and the consumable handover room to enter the clean passage. By the adoption of the clean cell production workshop, due to the facts that the people flow and the material flow are separated, and the one-way flow route design is adopted, the cross contamination caused by people flow and material flow routes is minimized.
Description
Technical field
The present invention relates to a kind of building, particularly a kind of cells produce clean room.
Background technology
Along with the progress of medical technology, cell therapy application is clinically more and more extensive, and the mode of small-scale Laboratory Production cell cannot satisfy the demands.Therefore there is the factory building of large-scale production cell.But there are the following problems for traditional cells produce factory building:
The first, the non-way flow circuit of the stream of people in factory building, clean area personnel Yi Zaocheng cross pollution.Stream line in factory building neither way flow, easily causes cross pollution.
The second, the cleaning apparatus that operand (referring to clinical grade cell) experiences is also not all under being in B level background, adds the possibility that operand pollutes.
3rd, when in operation room, a cleaning apparatus damages, overhaul of the equipments personnel need to enter clean area and keep in repair it, cause normal operating in this operating area to carry out.And after maintenance, room need carry out bromogeramine scouring, ozone-ultraviolet is sterilized, and consumes more manpower, financial resources and time.
4th, the air feed of existing CO2gas incubator, the gas cylinder all adopting every platform CO2gas incubator to be used alone oneself carries out the mode of air feed, has multiple stage CO2gas incubator in factory building, once there be the gas of indivedual gas cylinder to exhaust, CO2gas incubator can be caused to work.Therefore, need periodical inspection be carried out, but even if periodical inspection also cannot understand every platform in real time establish cushion gas situation, significantly increase because incubator abnormal work causes the risk of abnormal growth of cells.
5th, the cleanliness factor of decontamination room does not do requirement, makes material cleaning and sterilizing not reach requirement; And the clean article after decontamination are passed to clean area through non-clean area, article easily cause secondary pollution.
Six, with the operand only multidomain treat-ment separately of operation volatile hazardous substances, but air-conditioning, air draft are connected with other operating areas, may with other operand generation cross pollutions, or operator to be damaged.
7th, clean area humiture adopts the mode of time recording, airborne periodic detection, can not reach real-time monitoring, the object of process in time.
Above defect causes traditional factory building easily to pollute, and cell quality can not get effective guarantee.
Summary of the invention
The object of the present invention is to provide a kind of cells produce clean room, to minimize in mass cell manufacturing process, cell is subject to the factors such as environment to be affected and the problem of growth failure, thus ensures the quality of cell.
The invention provides a kind of cells produce clean room, it is characterized in that, comprising: decontamination room, for carrying out cleaning and sterilizing to logistics; Produce cleanroom, there is multiple operating unit, dressing room, the air lock be connected with dressing room and consumptive material transfer chamber; And between the positive, independent mutually with production cleanroom, have independent stream of people's logistics half-duplex channel, wherein, operating unit lines up two rows, clean corridor is formed in the middle of two row's operating units, the outside of two row's operating units forms dirt corridor, and consumptive material transfer chamber one end is connected by delivery window with decontamination room, and the other end is connected with the operating unit of foremost, the stream of people enters clean corridor by dressing room and air lock, and logistics enters clean corridor through decontamination room and consumptive material transfer chamber.
In addition, cells produce clean room of the present invention, such feature can also be had: wherein, operating unit has operating space and maintenance district, the entrance of operating space communicates with clean corridor, and the outlet of operating space communicates with dirt corridor, and entrance and exit place is provided with one-way isolation door, maintenance district is positioned at the back side of operating space, communicates with dirt corridor.
In addition, cells produce clean room of the present invention, can also have such feature: wherein, has cells produce equipment in operating unit, and the operating surface of cells produce equipment is arranged in operating space, and maintenance face is arranged in maintenance district.
In addition, cells produce clean room of the present invention, can also have such feature: wherein, and the top of cells produce equipment is provided with laminar flow hood, blows way flow pure air to cells produce equipment, makes cell manipulation environment cleanliness be A level under B level background.
In addition, cells produce clean room of the present invention, can also have such feature: also comprise gas cylinder room, and gas cylinder room is arranged at and produces outside cleanroom, is connected, to cells produce equipment air feed by gas pipeline with cells produce equipment.
In addition, cells produce clean room of the present invention, can also have such feature: wherein, and the environment cleanliness rank of decontamination room is C level, and is connected with consumptive material transfer chamber by delivery window.
In addition, cells produce clean room of the present invention, can also have such feature: also comprise first row wind system, for decontamination room and operating unit provide unidirectional cleaning gas tream; And second row wind system, for providing unidirectional cleaning gas tream between the positive, first row wind system and second row wind system do not communicate.
In addition, cells produce clean room of the present invention, can also have such feature: wherein, and produce in cleanroom and install temperature-humidity sensor, dust particle sampling pipe, by third party software Real-Time Monitoring ambient condition.
In addition, cells produce clean room of the present invention, can also have such feature: wherein, and cells produce equipment comprises CO2gas incubator, in CO2gas incubator, temperature, carbon dioxide sensor are installed, by third party software care testing device running status.
The beneficial effect of the invention
According to cells produce clean room of the present invention, due to stream of people's logistics shunting and the highway route design of one-way flow, therefore minimize the cross pollution that stream of people's logistics route brings.
In addition, due to safety cabinet, incubator, centrifuge, microscope, the equipment such as operating desk are all positioned at room laminar flow hood with lower area, and guarantee cell processing procedure is strictly in the A level under B level background, reduces the possibility of cell contamination.
In addition, because incubator, safety cabinet adopt the design of incarceration formula, equipment use district is placed in operating space, and maintenance district is placed in beyond operation room.After a device damage, maintenance can be carried out with operation simultaneously, can avoid overhauling the pollution brought to clean area simultaneously.
In addition, because carbon dioxide adopts central gas supply, gas surplus amount can be understood in time, make timely process.
In addition, because decontamination room is directly connected with production clean area by delivery window, shorten material and transmit distance, avoid the secondary pollution of material.
In addition, because clean area temperature humidity and dust particle are monitored in real time, therefore, it is possible to process room state is abnormal in time.
In addition, because clear production district cell cultivation equipment CO2gas incubator installs temperature carbon dioxide sensor, therefore, it is possible to processing device status is abnormal in time.
Accompanying drawing explanation
Fig. 1 is the overall structure schematic diagram of cells produce clean room;
Fig. 2 is the structural representation of operating unit;
Fig. 3 is the schematic diagram of exhaust system;
Fig. 4 is the distribution schematic diagram of steam line;
Fig. 5 is the distribution schematic diagram of steam line.
Detailed description of the invention
Below in conjunction with accompanying drawing, the specific embodiment of the present invention is described.
Fig. 1 is the overall structure schematic diagram of cells produce clean room, and as shown in Figure 1, cells produce clean room comprises: decontamination room 11, produces cleanroom 12, and between the positive 13.
The environment cleanliness rank of decontamination room 11 is C level, is provided with two-door sterilizing cabinet 111 and delivery window 112, is communicated by delivery window 112 with consumptive material transfer chamber 126 in decontamination room 11, shortens material and transmits distance, avoid the secondary pollution of material.Logistics enters after decontamination room 11 can send into consumptive material transfer chamber 126 through delivery window 112 from stream inlet.If logistics needs sterilizing, then need to send into consumptive material transfer chamber 126 again after the sterilizing of two-door sterilizing cabinet 111.
Produce in cleanroom 12 and there is multiple operating unit 123, dressing room 124, the air lock 127 be connected with dressing room 124 and consumptive material transfer chamber 126.
Connect in turn between each operating unit 123, as shown in Figure 1, the operating unit 123 in present embodiment has 12, and six one rows, line up two rows, forms the major trunk roads of stream of people's logistics corridor, i.e. clean corridor 122 between two row's operating units.The outside of two row's operating units forms dirt corridor 121.
The operating unit 123 be positioned at foremost is connected with consumptive material transfer chamber 126.Branched bottom has one-way isolation door, and the opening direction of one-way isolation door is the direction from major trunk roads to both sides branched bottom.The direct of travel of the stream of people and logistics is as shown in the direction of arrow in the people's flow path direction 128 in Fig. 1 and logistics direction 129.
The stream of people is introduced into dressing room 124 from people's inflow entrance and changes work clothes, then enters air lock 127, then enters clean corridor 122,
Fig. 2 is the structural representation of operating unit, shows the situation that two operating unit dorsal parts are oppositely arranged in Fig. 2.As shown in Figure 2, an operating unit 123 has a set of cells produce equipment, and cells produce equipment comprises: refrigerator 135, CO2gas incubator 136, safety cabinet 137 and workbench 138.Region drawn by oblique stroke shade is workbench 138 position.The formation operating space, side at workbench 138 place.Refrigerator 135, CO2gas incubator 136 and safety cabinet 137 incarceration are among body of wall, and one of equipment use is placed in operating space, and the dorsal part of equipment is placed in beyond operating space, two operating unit north sides relatively institute around space formed and overhaul district.Between two operating units, maintenance to be also separated with between consumptive material 125, for temporary consumptive material before district.The position in maintenance district, can make after a device damage, and maintenance is carried out with operation simultaneously, can avoid again the pollution brought to operating space when overhauling.The top of cells produce equipment is provided with laminar flow hood, blows way flow pure air to cells produce equipment.The cells produce equipment that need use during operation is as safety cabinet 137, incubator 126, centrifuge, microscope, workbench 138, all be positioned at room laminar flow hood with lower area, guarantee cell processing procedure is strictly in the A level under B level background, reduces the possibility of cell contamination.
Between the positive 13, process the operand with operation volatile hazardous substances, use II level B2 Biohazard Safety Equipments in 13 between the positive, and there is independent exhaust system in room, i.e. second row wind system, between the positive, 13 provide unidirectional cleaning gas tream, air draft be entirely arrange.The stream of people and logistics to be entered between the positive among 13 by different entrances, and stream of people's route 131 and logistics route 132 are as shown in Figure 1.
Fig. 3 is the schematic diagram of exhaust system, shows the position relationship of other structure in exhaust system and factory building, and independent exhaust system as shown in Figure 4.What Fig. 4 a showed is first row wind system, for decontamination room and operating unit provide unidirectional cleaning gas tream; First row wind system has main exhaust duct 15 as shown in fig. 4 a, and branch row wind pipeline 151, and main exhaust duct 15 has air outlet 152 every a segment distance.Air outlet 153 is all had above each operating space.Represent air outlet 153 with the square dice at every bar pipeline end place in figure, label marks no longer one by one.
Fig. 4 b shows the structure of second row wind system, and as shown in Figure 2, second row wind system does not communicate with first row wind system.Second row wind system has multiple air outlet, opens respectively above people's circulation road and operating space, makes people's circulation road and operating space keep clean.
Fig. 5 is the distribution schematic diagram of steam line, as shown in Figure 5, the CO2gas incubator of each operating unit and positive sound or other gas needed for cells produce equipment provide by gas cylinder room 16 is unified, gas cylinder room is arranged at and produces outside cleanroom, by three articles of gas pipelines: the first gas pipeline 161, second gas pipeline 162, the 3rd gas pipeline 163 need the cells produce equipment of gas to be connected with CO2gas incubator or other, to cells produce equipment air feed.Because gas cylinder room 16 is arranged at outside operating unit 123, therefore facilitate the service condition of Centralized Monitoring gas.In addition, when there being the gas of gas cylinder to exhaust, when needing to change, the cleaning area also not needing operating personnel to enter into operating unit 123 is changed, and avoids Migrant women and produces pollution to the environment in operating unit 123.
Operating unit in cells produce clean room and all install humidity temperature pickup and display screen between the positive, and by third party software image data, realize humiture real time and on line monitoring, when humiture exceedes preset value, then carry out SMS alarm.Dust particle sampling pipe is installed in each room, by third party software image data, realizes dust particle real-time online and controls.Incubator installs humiture and carbon dioxide sensor, by third party software image data, realizes equipment running status real time and on line monitoring, when equipment state exceedes preset value, then realizes SMS alarm, to process in time.
Claims (9)
1. a cells produce clean room, is characterized in that, comprising:
Decontamination room, for carrying out cleaning and sterilizing to logistics;
Produce cleanroom, there is multiple operating unit, dressing room, the air lock be connected with dressing room and consumptive material transfer chamber; And
Between the positive, independent mutually with production cleanroom, there is independent stream of people's logistics half-duplex channel,
Wherein, described operating unit lines up two rows, forms clean corridor in the middle of the described operating unit of two rows, and the outside of two row's operating units forms dirt corridor,
Described consumptive material transfer chamber one end is connected by delivery window with described decontamination room, and the other end is connected with the described operating unit of foremost,
The stream of people enters described clean corridor by dressing room and air lock, and logistics enters described clean corridor through decontamination room and consumptive material transfer chamber.
2. cells produce clean room according to claim 1, is characterized in that:
Wherein, described operating unit has operating space and maintenance district, the entrance of described operating space communicates with described clean corridor, the outlet of described operating space communicates with described dirt corridor, described entrance and described exit are provided with one-way isolation door, described maintenance district is positioned at the back side of described operating space, communicates with described dirt corridor.
3. cells produce clean room according to claim 2, is characterized in that:
Wherein, have cells produce equipment in described operating unit, the operating surface of described cells produce equipment is arranged in described operating space, and maintenance face is arranged in described maintenance district.
4. cells produce clean room according to claim 4, is characterized in that:
Wherein, the top of described cells produce equipment is provided with laminar flow hood, blows way flow pure air to described cells produce equipment, makes cell manipulation environment cleanliness be A level under B level background.
5. cells produce clean room according to claim 4, is characterized in that, also comprise:
Gas cylinder room, described gas cylinder room is arranged at outside described production cleanroom, is connected with described cells produce equipment by gas pipeline, to described cells produce equipment air feed.
6. cells produce clean room according to claim 1, is characterized in that:
Wherein, the environment cleanliness rank of described decontamination room is C level, and is connected with described consumptive material transfer chamber by delivery window.
7. cells produce clean room according to claim 1, is characterized in that, also comprise:
First row wind system, for described decontamination room and described operating unit provide unidirectional cleaning gas tream; And
Second row wind system, for providing unidirectional cleaning gas tream between the described positive,
Described first row wind system and described second row wind system do not communicate.
8. cells produce clean room according to claim 1, is characterized in that:
Wherein, install temperature-humidity sensor in described production cleanroom, dust particle sampling pipe, by third party software Real-Time Monitoring ambient condition.
9. cells produce clean room according to claim 1, is characterized in that:
Wherein, described cells produce equipment comprises CO2gas incubator, installs temperature, carbon dioxide sensor, by third party software care testing device running status in described CO2gas incubator.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510172240.4A CN104847139B (en) | 2015-04-13 | 2015-04-13 | Cell produces clean room |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510172240.4A CN104847139B (en) | 2015-04-13 | 2015-04-13 | Cell produces clean room |
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| CN104847139B CN104847139B (en) | 2017-09-29 |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106401224A (en) * | 2016-11-24 | 2017-02-15 | 中国电子工程设计院 | Clean room factory structure |
| CN106958363A (en) * | 2016-01-08 | 2017-07-18 | 正大天晴药业集团股份有限公司 | A kind of production plot structure in biological medicine workshop |
| CN106988567A (en) * | 2017-04-24 | 2017-07-28 | 中船第九设计研究院工程有限公司 | A kind of design method of Experiment on Microbiology process layout |
| CN107558759A (en) * | 2017-07-28 | 2018-01-09 | 广东依浦赛生物科技有限公司 | Medical cell prepare between and its application method |
| CN108220161A (en) * | 2018-01-24 | 2018-06-29 | 北京臻溪谷医学研究中心（有限合伙） | A kind of many cells prepare laboratory placement scheme |
| CN109469362A (en) * | 2018-10-23 | 2019-03-15 | 广州达意隆包装机械股份有限公司 | A kind of laboratory |
| CN110469162A (en) * | 2019-08-21 | 2019-11-19 | 杭州奕安济世生物药业有限公司 | Clean room overall structure and workshop operation method for medicine production |
| CN110761594A (en) * | 2019-01-24 | 2020-02-07 | 中船第九设计研究院工程有限公司 | Clinical cell preparation engineering environment barrier system |
| CN114215395A (en) * | 2021-12-14 | 2022-03-22 | 北部湾大学 | Animal isolated cell laboratory |
| CN114829719A (en) * | 2019-12-16 | 2022-07-29 | 科奥利浦思株式会社 | Apparatus and method for manufacturing article using the same |
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| CN101400781A (en) * | 2006-03-10 | 2009-04-01 | 世元世龙技术株式会社 | Facility module for production and storage of cell therapy product |
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Cited By (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106958363A (en) * | 2016-01-08 | 2017-07-18 | 正大天晴药业集团股份有限公司 | A kind of production plot structure in biological medicine workshop |
| CN106401224A (en) * | 2016-11-24 | 2017-02-15 | 中国电子工程设计院 | Clean room factory structure |
| CN106988567B (en) * | 2017-04-24 | 2019-04-02 | 中船第九设计研究院工程有限公司 | A kind of design method of Experiment on Microbiology process layout |
| CN106988567A (en) * | 2017-04-24 | 2017-07-28 | 中船第九设计研究院工程有限公司 | A kind of design method of Experiment on Microbiology process layout |
| CN107558759A (en) * | 2017-07-28 | 2018-01-09 | 广东依浦赛生物科技有限公司 | Medical cell prepare between and its application method |
| CN108220161A (en) * | 2018-01-24 | 2018-06-29 | 北京臻溪谷医学研究中心（有限合伙） | A kind of many cells prepare laboratory placement scheme |
| CN108220161B (en) * | 2018-01-24 | 2022-06-14 | 北京臻溪谷医学研究中心（有限合伙） | Laboratory layout scheme for multi-cell preparation |
| CN109469362A (en) * | 2018-10-23 | 2019-03-15 | 广州达意隆包装机械股份有限公司 | A kind of laboratory |
| CN110761594A (en) * | 2019-01-24 | 2020-02-07 | 中船第九设计研究院工程有限公司 | Clinical cell preparation engineering environment barrier system |
| CN110761594B (en) * | 2019-01-24 | 2021-07-09 | 中船第九设计研究院工程有限公司 | Clinical cell preparation engineering environment barrier system |
| CN110469162A (en) * | 2019-08-21 | 2019-11-19 | 杭州奕安济世生物药业有限公司 | Clean room overall structure and workshop operation method for medicine production |
| CN114829719A (en) * | 2019-12-16 | 2022-07-29 | 科奥利浦思株式会社 | Apparatus and method for manufacturing article using the same |
| CN114215395A (en) * | 2021-12-14 | 2022-03-22 | 北部湾大学 | Animal isolated cell laboratory |
| CN114215395B (en) * | 2021-12-14 | 2023-09-19 | 北部湾大学 | Animal ex vivo cell laboratory |
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Address after: 201318 Shanghai City, Pudong New Area Road No. 588 building 3 indigo Applicant after: SHANGHAI ANGECON BIOTECHNOLOGY CO., LTD. Address before: 201318 Shanghai City, Pudong New Area Road No. 588 building 3 indigo Applicant before: Shanghai Angecon Biotechnology Co., Ltd. |
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